Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:65 - Any
Updated:4/2/2016
Start Date:April 2012
Contact:Angelo Volandes, MD
Email:avolandes@partners.org
Phone:617 643 4266

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The purpose of this study is to compare the decision making of subjects with advanced CHF
having a verbal discussion about goals of care compared to subjects using a video.

Aim #1: To compare the impact of the intervention on the distribution of end-of-life
knowledge, decisional conflict, and preferences among 248 subjects with advanced heart
failure randomly assigned to one of two ACP modalities: 1. a video visually depicting the
goals of care along with a patient checklist (intervention, 124 subjects), or 2. usual care,
i.e., verbal narrative (control, 124 subjects).

Hypothesis #1: Compared to subjects randomized to the verbal narrative group, subjects
randomized to the video intervention will be significantly more likely to:

1a. Have more knowledge about their choices

1b. Have less decisional conflict about their decisions

1c. Opt for comfort care and less likely to choose life-prolonging measures

Aim #2: To compare stability of preferences over time (1, 3, and 6 months), concordance rate
of preferences (preferences expressed vs. preferences documented in the medical record -
both inpatient and outpatient records), and advance care planning discussions (as reported
by the patient), among 248 subjects randomized to the video (N=124) vs. verbal narrative
(N=124).

Hypothesis #2: Compared to subjects randomized to the verbal narrative group, subjects
randomized to the video intervention will be significantly more likely to:

1a. Have more stable preferences over time

1b. Higher concordance rates

1c. Have had an advance care planning discussion

Aim #3: To compare quality of life, anxiety and depression, referral to hospice, place of
death, after death bereavement (caregiver), and resource utilization after 6 months and 1
year (or death) among 248 subjects randomized to the video (N=124) vs. verbal narrative
(N=124).

Hypothesis #3: Compared to subjects randomized to the verbal narrative group, subjects
randomized to the video intervention will be significantly more likely to:

1a. Have a better quality of life (FACIT-Pal, FACIT-Sp-12)

1b. Have earlier referral to hospice in subjects who die

1d. Die at home or hospice (or inpatient hospice setting) in subjects who die

1e. Have better caregiver bereavement score (for caregiver subjects who die).

Inclusion Criteria:

1. A diagnosis of advanced heart failure as defined by ALL THREE of the following:

• New York Heart Association Class III or IV (NYHA III or IV) (III: marked limitation
in activity due to symptoms, even during less-than-ordinary activity; IV: severe
limitations, experiences symptoms while at rest).

AND

- Hospitalization for heart failure within the last six months. AND

- Age greater than or equal to 65.

2. Additionally ONE of the following must be met:

- According to the attending physician's best judgment the patient's survival is
limited to 2 years but may very well be less than 1 year (i.e. the physician
would not be surprised if the patient died within one year from any cause) OR

- Three heart failure hospitalizations in the last year OR

- One of the following:

- Two Systolic Blood Pressures < 90 within the last 6 months in the
ambulatory setting

- Na < 130 within the last 6 months

- NTproBNP > 3,000

- EGFR < 35

- High diuretic use (160 mg po Lasix or 100 mg po torsemide or equivalent
total daily dose)

Exclusion Criteria:

- New patient

- A transplant or mechanical circulatory support candidate

- Major psychiatric illness as determined by the attending that would make this study
inappropriate.

- Any patient that has been excluded for transplant or mechanical circulatory support
due to psychological or psychiatric co-morbidities.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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mi
from
Boston, MA
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